Olympus Corp. said it will voluntarily recall and redesign a troubled medical scope that has been linked to scores of potentially deadly patient infections around the world.
The company, which sells about 85 percent of the duodenoscopes used in the United States, said it will redesign an internal mechanism in the device that had been almost impossible to effectively disinfect.
A Senate report released this week said investigators had found 25 superbug outbreaks linked to the scopes. The devices were made by Olympus and two other manufacturers. It is unclear whether the other manufacturers will redesign their scopes.
From 2012-15, investigators said, at least 141 patients in nine U.S. cities were infected.
A series of Los Angeles Times stories last year reported that Olympus knew of the potential flaws in the scope but failed to alert American hospitals or regulators.
The U.S. Food and Drug Administration has approved the steps announced Friday, Olympus said.
A lawmaker behind the Senate investigation praised the move and urged further action.
“These devices exposed far too many patients and their families to unacceptable risks, and I am pleased to see that the FDA and manufacturers have taken additional actions to protect patients in the future,” said Sen. Patty Murray, D-Wash., who initiated the investigation after dozens of patients were sickened at a Seattle hospital.
“The steps taken today are important, but there is much more we need to do to make sure the FDA can respond quickly and appropriately when problems with medical devices occur,” she said in a statement.
The report — written by the minority staff of the Senate committee on health, education, labor and pensions and released Wednesday — cited repeated failures by manufacturers, regulators and hospitals to report outbreaks. That oversight allowed patients to remain at risk “with life-threatening consequences,” investigators determined.
Rep. Ted Lieu, D-Calif., who serves on the House Committee on Oversight and Government Reform, greeted Friday’s announcement with a more scathing tone.
“Had Olympus initiated this recall sooner,” he said in a statement, “numerous patients would not have been infected with antibiotic-resistant superbugs.”
“Olympus’ decision needs to be monitored to determine its effectiveness since previous claims of effectiveness by Olympus have proven not to work,” he said. “I also urge Pentax and Fuji, the other major duodenoscope manufacturers, to fix their design problems and recall their duodenoscopes.”
The duodenoscope is used in a procedure known as ERCP, or endoscopic retrograde cholangiopancreatography. Doctors thread the flexible scope down a patient’s throat and into the digestive tract to diagnose and treat cancers, gallstones and other conditions.
Olympus had redesigned its $40,000 duodenoscope in 2010 to seal a narrow internal channel and keep out blood and other infectious material. The change was intended to make the scope easier to clean.
But three independent investigations — the first in 2012 — found that the design could allow bacteria to remain inside the scope even after it was cleaned according to Olympus’ instructions.
The Senate report backed up those findings, noting it “is now evident” that such models can “trap and transmit bacteria” even after cleaning.
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